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Trial of Active Immunotherapy With OBI-833 (Globo H-CRM197) in Advanced/Metastatic Gastric, Lung, Colorectal or Breast Cancer Subjects

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ClinicalTrials.gov Identifier: NCT02310464
Recruitment Status : Recruiting
First Posted : December 8, 2014
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
OBI Pharma, Inc

Brief Summary:
The purpose of this clinical study is to assess the safety and tolerability and efficacy of active immunotherapy with dose escalation and cohort expansion of OBI-833 in advanced/metastatic gastric, lung, colorectal, or breast cancer subjects.

Condition or disease Intervention/treatment Phase
Metastatic Gastric Cancer Metastatic Breast Cancer Metastatic Colorectal Cancer Metastatic Lung Cancer Drug: OBI-833/OBI-821 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Assess the Safety, Tolerability, and Efficacy of Active Immunotherapy With Dose Escalation and Cohort Expansion of OBI-833 (Globo H-CRM197) in Advanced/Metastatic Gastric, Lung, Colorectal, or Breast Cancer Subjects
Study Start Date : December 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Dose escalation
Each subject will be given a total of 10 doses of OBI-833/OBI-821 subcutaneously at weeks 1,2,3,4,6,8,12,16,20,and 24 (Visits 1,2,3,4,5,6,7,8,9 and 10, respectively). Post treatment, subjects will be continually evaluated for safety and immune response every 4 weeks until the end of study, which is 12 weeks after the last dose, i.e., week 36. Subsequently, subjects will be followed for survival every 8 weeks up to 12 months after the end of study.
Drug: OBI-833/OBI-821
Experimental: Cohort expansion phase
Each subject will be given OBI-833/OBI-821 at Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, and every 8 weeks thereafter (Visits 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and every 8 weeks thereafter) until disease progression. For the subjects discontinued treatment because of disease progression, subjects will be continually evaluated for safety and immune response every 8 weeks until the end of the study, which is 24 weeks after the last dose.
Drug: OBI-833/OBI-821



Primary Outcome Measures :
  1. Safety and tolerability assessed by adverse events, changes in laboratory values, and changes in vital signs. [ Time Frame: 36 weeks ]


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects ≥21 years of age
  2. Dose escalation phase: Histologically or cytologically confirmed diagnosis of gastric, lung, colorectal or breast cancer on file Cohort expansion phase: Histologically or cytologically confirmed diagnosis of Globo H-positive NSCLC
  3. Dose escalation: Subjects with recurrent or metastatic incurable disease that failed to respond to at least one line of anticancer standard therapy and for which standard treatment is no longer effective or tolerable.

    Cohort expansion phase: Subjects with recurrent or metastatic NSCLC who have achieved stable disease (SD), or partial response (PR) status after at least 1 regimen of anticancer therapy (i.e., chemotherapy, or targeted therapy, or PD-1/PD-L1 antagonists either alone or in combination) , and there are no standard treatments available except permitted Target or PD-1/PD-L1 therapies

  4. Measurable disease (i.e., present with at least one measurable lesion per RECIST, version 1.1.
  5. Dose Escalation Phase: No known central nervous system (CNS) metastases or neurological symptoms possibly related to active CNS metastasis in Dose Escalation Phase.

    Cohort Expansion Phase: Subjects with asymptomatic CNS metastases for at least four weeks before study drug treatment

  6. Performance status: ECOG ≤ 1
  7. Organ Function Requirements - Subjects must have adequate organ functions as defined below:

    AST/ALT ≤ 3X ULN (upper limit of normal) AST/ALT ≤ 5X ULN [with underlying liver metastasis] Total bilirubin ≤ 2.0 X ULN Serum creatinine ≤ 1.5X ULN ANC ≥ 1500 /µL Platelets > 100,000/µL

  8. Subjects of child-bearing potential must agree to use acceptable contraceptive methods during treatment and until the end of the study. Subject not of childbearing potential (i.e., permanently sterilized, postmenopausal) can be included in study. Postmenopausal is defined as 12 months with no menses without an alternative medical cause.
  9. Ability to understand and the willingness to sign a written informed consent document according to institutional guidelines.

Exclusion Criteria:

  1. Patients who have not received standard chemotherapy, hormonal or targeted therapy for their underlying advanced/metastatic cancer.
  2. Subjects who are pregnant or breast-feeding at entry.
  3. Subjects with splenectomy.
  4. Subjects with known or clinically manifest, symptomatic CNS metastases in Dose Escalation Phase.
  5. Subjects with HIV infection, active hepatitis B infection or active hepatitis C infection.
  6. Subjects with any autoimmune disorders requiring iv/oral steroids or immunosuppressive or immunomodulatory therapies.

    - e.g., Type 1 juvenile onset diabetes mellitus, antibody positive for rheumatoid arthritis, Grave's disease, Hashimoto's thyroiditis, lupus, scleroderma, systemic vasculitis, hemolytic anemia, immune mediated thrombocytopenia, etc.

  7. Subjects with any known uncontrolled inter-current illness including ongoing or active infections, symptomatic congestive heart failure (NYHA>2), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  8. Dose escalation phase: Subjects with any of the following MEDICATIONS within 4 weeks prior to IP treatment, except permitted therapies as listed in section 7.1:

    • Chemotherapeutic Agent
    • Immunotherapy [mAbs, Interferons, Cytokines (except GCSF)]
    • Immunosuppressants (e.g., cyclosporin, rapamycin, tacrolimus, rituximab, alemtuzumab, natalizumab, etc.).
    • IV/oral steroids except single prophylactic use in CT/MRI scan or other one-time use in approved indications. The interval between IV/oral steroids administration and first dose of OBI-833/OBI-821 must be more than pharmacological duration or 5 half-lives of administered steroids, whichever is the longer. Uses of inhaled and topical use of steroids are allowed.
    • Another investigational drug

    Cohort Expansion Phase: Subjects with any of the following MEDICATIONS within 4 weeks prior to IP treatment, except permitted therapies:

    • Chemotherapeutic Agent
    • Immunotherapy [Interferons, Cytokines] (except PD-1/PD-L1 antagonists)
    • Immunosuppressants (e.g., cyclosporin, rapamycin, tacrolimus, rituximab, alemtuzumab, natalizumab, etc.).
    • IV/oral steroids except single prophylactic use in CT/MRI scan or other one-time use in approved indications. The interval between IV/oral steroids administration and first dose of OBI-833/OBI-821 must be more than pharmacological duration or 5 half-lives of administered steroids, whichever is longer. Uses of inhaled and topical steroids are allowed.
    • Another investigational drug
  9. Subjects with pleural effusions and/or ascites, due to malignancy, requiring paracentesis every 2 weeks or more frequently.
  10. Subjects with any known severe allergies (e.g., anaphylaxis) to any active or inactive ingredients in the study drugs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310464


Contacts
Contact: Liz Yu +886-2-27866589 ext 208 lyu@obipharma.com

Locations
United States, Ohio
Gabrail Cancer Center Research Recruiting
Canton, Ohio, United States, 44718
Principal Investigator: OBI Pharma, Inc. OBI Pharma, Inc.         
United States, Texas
Mary Crowley Cancer Research Center Recruiting
Dallas, Texas, United States, 75230
Principal Investigator: OBI Pharma, Inc. OBI Pharma, Inc.         
Taiwan
Taipei Medical University Shuang Ho Hospital Recruiting
New Taipei City, Taiwan, 23561
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Principal Investigator: OBI Pharma, Inc. OBI Pharma, Inc.         
Taipei Medical University Hospital Recruiting
Taipei, Taiwan, 11031
Tri-Service General Hospital Recruiting
Taipei, Taiwan, 114
Sponsors and Collaborators
OBI Pharma, Inc

Responsible Party: OBI Pharma, Inc
ClinicalTrials.gov Identifier: NCT02310464     History of Changes
Other Study ID Numbers: OBI-833-001
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Stomach Neoplasms
Lung Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Stomach Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases